FDA 510(k) Chemistry Devices
FDA 510(k) Chemistry Devices - Regulatory Overview
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
JIT
Calibrator, Secondary
78d
Cleared
Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
JJY
Multi-analyte Controls, All Kinds (assayed)
69d
Cleared
Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
DIF
Drug Mixture Control Materials
76d
Cleared
Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
CEM
Electrode, Ion Specific, Potassium
29d
Cleared
Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
JJY
Multi-analyte Controls, All Kinds (assayed)
58d
Cleared
Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
JFM
Enzymatic Method, Bilirubin
345d
Cleared
Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
JHI
Visual, Pregnancy Hcg, Prescription Use
113d
Cleared
Dec 04, 2007
MICROPROTEIN REAGENT SET
JGP
Lowry (colorimetric), Total Protein
259d
Cleared
Dec 03, 2007
CREATININE (ENZYMATIC)
JFY
Enzymatic Method, Creatinine
252d
Cleared
Dec 03, 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
NBW
System, Test, Blood Glucose, Over The Counter
333d
Cleared
Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
60d
Cleared
Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
CGX
Alkaline Picrate, Colorimetry, Creatinine
121d
Cleared
Nov 26, 2007
PRIMUS A1CARE ASSAY
LCP
Assay, Glycosylated Hemoglobin
446d
Cleared
Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
CDD
Radioassay, Vitamin B12
195d
Cleared
Nov 09, 2007
ACCESSA CHOLESTEROL PANEL
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
316d
Cleared
Nov 06, 2007
GENTIAN CYSTATIN C IMMUNOASSAY
NDY
Test, Cystatin C
172d
Cleared
Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
LFR
Glucose Dehydrogenase, Glucose
209d
Cleared
Oct 26, 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
NBW
System, Test, Blood Glucose, Over The Counter
149d
Cleared
Oct 22, 2007
QUANTRX FEMALE FERTILITY TEST
NGA
Test, Follicle Stimulating Hormone (fsh), Over The Counter
244d
Cleared
Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
JGQ
Turbidimetric, Total Protein
31d
Cleared
Oct 19, 2007
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
386d
Cleared
Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
JIX
Calibrator, Multi-analyte Mixture
48d
Cleared
Oct 15, 2007
PTS PANELS CHOL+HDL PANEL TEST STRIPS
CHH
Enzymatic Esterase--oxidase, Cholesterol
126d
Cleared
Oct 15, 2007
AMNISCREEN HOME DETECTION LINER KIT
CEN
Dye-indicator, Ph (urinary, Non-quantitative)
179d
Cleared
Oct 12, 2007
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
269d
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